Notice2025-11962
Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
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Published
June 27, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the accreditation of third-party certification bodies to conduct food safety audits and issue certifications.
Full Text
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<title>Federal Register, Volume 90 Issue 122 (Friday, June 27, 2025)</title>
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[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27625-27628]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11962]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5579]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Accreditation of Third-Party Certification Bodies To
Conduct Food Safety Audits and Issue Certifications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the
[[Page 27626]]
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for the accreditation of third-party certification bodies
to conduct food safety audits and issue certifications.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 26, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 26, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-5579 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Accreditation of Third-Party
Certification Bodies to Conduct Food Safety Audits and Issue
Certifications.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#316163706245505757715755501f5959421f565e47"><span class="__cf_email__" data-cfemail="37676576644356515177515356195f5f4419505841">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Accreditation of Third-Party Certification Bodies To Conduct Food
Safety Audits and Issue Certifications--21 CFR Part 1, Subpart M
OMB Control Number 0910-0750--Extension
This information collection supports FDA's Accredited Third-Party
Certification Program (also referred to as the third-party food program
or TPP), administered under section 808 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 384d), and codified in 21 CFR part
1, subpart M (21
[[Page 27627]]
CFR 1.600 through 1.725) of Agency regulations. The regulation
communicates eligibility criteria, assessment standards, and
establishes procedures and requirements for participation. For more
information visit our website at <a href="https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program">https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program</a>.
Under TPP, accreditation bodies (ABs) apply to FDA for recognition.
Recognized ABs accredit third-party certification bodies (CBs) under
the program, except in limited circumstances. The accredited CBs
conduct food safety audits and issue food or facility certifications to
eligible foreign entities. Section 808(c)(2)(B) of the FD&C Act
specifies that FDA uses certifications issued by accredited CBs under
TPP in deciding whether to admit certain imported food (both food for
human and food for animals) into the United States that we have
determined poses a food safety risk under section 801(q) of the FD&C
Act (21 U.S.C. 381(q)) and in deciding whether an importer is eligible
to participate in a program for expedited review and entry under
section 806 of the FD&C Act (21 U.S.C. 384b). Under TPP, FDA may grant
recognition of an AB for up to 5 years from the date of recognition.
There are current AB participants that are recognized through fiscal
year 2027 or 2028 and will need to submit renewal of recognition
applications to continue their participation. Specific requirements and
procedures are found in 21 CFR part 1, subpart M.
There are approximately 200,000 foreign food (both food for human
and food for animals) exporters who offer their food products for
import into the United States. These foreign food exporters include
approximately 130,000 food production facilities and approximately
71,000 farms. A proportion of these foreign food exporters may offer
food subject to mandatory certification requirements under section
801(q)(3) of the FD&C Act. In that case, to continue importing food
products into the United States, eligible entities must either obtain
certification from a CB accredited under TPP, or obtain certification
from a foreign government designated by FDA. We assume in any given
year, 75 foreign food exporters will be subject to requirements in
section 801(q) of the FD&C Act.
Use of accredited CBs and food and facility certifications issued
under TPP helps reduce the number of redundant audits necessary to
assess compliance with food safety requirements of the FD&C Act and
applicable regulations. We have developed Forms FDA 3997 and FDA 3997a
to enable respondents to submit required data elements using FDA's
Unified Registration Listing System (FURLS), an electronic portal
(Forms FDA 3997 for ABs and 3997a for CBs) that enables respondents to
complete data fields and provide information to FDA electronically. The
AB and CB portals provide a standardized format for entering
information, prompting respondents for input, and facilitating FDA's
review of the submittal. Respondents are subject to user fees for
application, renewal, and annual fees, as set forth in 21 CFR 1.700
through 1.725. The user fee rates are calculated each fiscal year and
published in the Federal Register before the start of a new fiscal
year. Electronic portal instructions and user fee information may be
accessed at <a href="https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program">https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program</a>.
Respondents to the collection of information are the accredited CBs
that conduct audits and issue certifications to eligible entities, the
ABs and CBs seeking to participate in TPP, and the recognized ABs and
accredited CBs complying with the TPP requirements. An accredited CB is
a foreign government, agency of a foreign government, foreign
cooperative, or any other third party that a recognized AB (or, in the
case of direct accreditation, FDA) has determined meets the applicable
requirements of TPP and is accredited to conduct food safety audits and
to issue food or facility certifications to eligible entities. An AB is
an authority, such as a private third-party, foreign government, or
foreign agency, that performs accreditation of CBs. A recognized AB is
an AB that FDA has determined meets the applicable requirements of TPP
and is authorized to accredit CBs under TPP.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
21 CFR part 1; subpart M Number of responses per annual Average burden per Total hours
respondents respondent \2\ responses response \2\
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AB applications, 25 11.36 284 3.18.................... 903
applications for renewals,
notifications, and
revocations.
CB certifications, 208 147.30 30,638 0.25 (15 minutes)....... 7,660
regulatory audits and
assessments, notifications.
CB applications for direct 1 1 1 90...................... 90
accreditation & renewal.
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Total................... .............. .............. 30,923 ........................ 8,653
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\1\ There are no capital costs or operating and maintenance costs associated with annual reporting.
\2\ Figures rounded to nearest 1/100th as calculated based on total number of records and hours.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Number of records per Total Average burden per
21 CFR part 1; subpart M recordkeepers recordkeeper annual recordkeeping \2\ Total hours
\2\ records
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AB documenting procedures 25 426.56 10,664 0.25 (15 minutes)....... 2,666
for accreditation;
maintaining applicable
records.
AB establishing and updating 25 1 25 52.8.................... 1,320
public list of CBs.
CB documenting certification 208 113.04 23,512 0.35 (~20 minutes)...... 8,229
procedures; maintaining
applicable records (audits,
certifications, serious
risks).
CB establishing and updating 208 1.31 273 44.19................... 12,064
public list of eligible
entities.
[[Page 27628]]
Contract modification....... 7 9 63 2....................... 126
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Total................... .............. .............. 34,537 ........................ 24,405
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\1\ There are no capital or operating and maintenance costs associated with the annual recordkeeping burden.
\2\ Figures rounded to the nearest 1/100th as calculated based on total number of records and hours.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11962 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P
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